for therapeutic drug monitoring

Transcription

1 Thermo Scientific TDM Assays for Therapeutic Drug Monitoring Complete solutions for therapeutic drug monitoring TDM tests provide quantitative results to ensure beneficial therapeutic effects by determining the drug concentration in blood.

2 We provide a broad range of therapeutic drug monitoring (TDM) assays including full menus of Antibiotics, Antiepileptics, Antiarrhythmics, plus Theophylline. All of these assays provide outstanding performance with excellent accuracy, precision, sensitivity and specificity. Applications are available on our Thermo Scientific Indiko and Indiko Plus clinical and specialty chemistry analyzers and for most major laboratory instrumentation. What are TDMs and why do they need monitoring? TDM tests provide quantitative results to ensure beneficial therapeutic effects by determining the drug concentration in blood. Too much drug can cause toxicity and too little, a lack of efficacy. Additionally individual patient factors such as age, ethnicity, metabolism and history can affect the drug performance. TDM s aid physicians in determining the optimal drug dosage for an individual patient by monitoring serum or plasma drug concentrations to ensure effectiveness and patient compliance. Toxicity Plasma or Serum Concentration of the Drug TDM Lack of Efficacy Desired Effect Jain, K.K., Therapeutic Drug Monitoring Technologies, Companies and Markets, Jain PharmaBiotech, Basel, Switzerland, Tech Report, p.14. February

3 ANTIBIOTICS Optimize patient dosages with Thermo Scientific Antibiotic Assays Antibiotic TDMs are used in life threatening infections where serious side-effects can occur if the drug concentration exceeds the therapeutic range. Patients are often hepatically or renally impaired causing the metabolism and clearance of the drug to be unpredictable. Therefore monitoring patients for these antibiotics is extremely important. Our menu of Antibiotics includes: Amikacin, Gentamicin, Tobramycin, Teicoplanin* and Vancomycin. Each assay provides high quality results with fast turnaround times. The assays are all robust and available on a wide variety of instrumentation. Our easy-to-use Indiko and Indiko Plus clinical and specialty chemistry analyzers are the ideal platform for running the assays. We also have applications for most major clinical laboratory systems. Antibiotics Product Performance Total Precision (%CV) Method Comparison Assay Range Low Medium High Comparison Correlation Slope Intercept Method Coefficient Amikacin µg/ml FPIA Gentamicin (CEDIA) µg/ml FPIA Gentamicin () µg/ml FPIA Teicoplanin* µg/ml FPIA Tobramycin µg/ml FPIA Vancomycin µg/ml FPIA *Teicoplanin is not available for sale in the US. 3

4 ANTIEPILEPTICS Ensure the highest levels of performance with Thermo Scientific Antiepileptic Assays Antiepileptic drugs (AED) are commonly used to treat seizures. This class of TDMs is the most commonly monitored. As with all TDMs, AED s are monitored for dosage within a narrow therapeutic range, patient compliance, and challenging pharmacokinetics. We have one of the most comprehensive menus of AED s including many of the newer generation drugs. Our menu includes: Carbamazepine, Lamotrigine, Phenobarbital, Phenyotin, Topiramate, Valproic Acid and Zonisamide. Multi Constituent Calibrators are available for most of our AED assays. All of our AED assays are accurate and precise to ensure the highest levels of performance. Thermo Scientific Indiko and Indiko Plus clinical and specialty chemistry bench top analyzers with bar-coded bottles make testing fast and easy. We also have applications for most of the major clinical laboratory systems. Antiepiletptics Product Performance Total Precision (%CV) Method Comparison Assay Range Comparison Correlation Low Medium High Slope Intercept Method Coefficient Carbamazepine µg/ml FPIA Lamotrigine µg/ml HPLC Phenobarbital µg/ml FPIA Phenytoin* µg/ml FPIA Topiramate µg/ml FPIA Valproic Acid µg/ml FPIA Zonisamide 3-50 µg/ml HPLC *Run-to Run precision listed 4

5 ANTIARRHYTHMICS Reliable, sensitive and specific assays are the cornerstone of the Thermo Scientific Antiarrhythmics Assays Antiarrhythmics drugs are used in the treatment of cardiac arrhythmias. Each is used to monitor patients to ensure they are receiving the optimal dosage to prevent any toxic adverse effects. We are a leading supplier of antiarrhythmics assays including: Digoxin, Digitoxin, Lidocaine, N-Acetylprocainamide (NAPA), Procainamide, and Quinidine. Each assay is rigorously tested to ensure it provides the accuracy, precision, sensitivity and specificity required. Applications are available for a wide variety of laboratory instrumentation and will be available soon on the the Thermo Scientific Indiko and Indiko plus clinical and specialty chemistry systems. Antiarrhythmics Product Performance Total Precision (%CV) Method Comparison (FPIA) Assay Range Correlation Low Medium High Slope Intercept Coefficient Digoxin* ng/ml Digitoxin* 3-50 ng/ml Lidocaine ng/ml NAPA ng/ml Procainimide ng/ml Quinidine ng/ml *Run-to Run precision listed Bronchodilator Product Performance Theophylline is a bronchodilator used in the treatment of asthma, obstructive lung disease and neonatal apnea. The Thermo Scientific CEDIA Theophylline II assay has a proven track record providing consistent, reliable results that you can count on. Total Precision (%CV) Method Comparison (FPIA) Assay Range Correlation Low Medium High Slope Intercept Coefficient Theophylline µg/ml

6 MAS QUALITY CONTROLS Thermo Scientific MAS third party quality controls are available for the TDM assays and provide an unbiased and independent assessment of the laboratory s testing system. We are simplifying QC by providing: Products that are liquid, ready to use Target levels optimized for all key analytes Consolidated multi-consituent controls Thermo Scientific MAS LabLink xl, an easy to use, real-time, web-based quality assurance program MAS PAR TDM Controls MAS Par TDM is a multi-constituent, assayed TDM control designed for use on automated analyzers. It is liquid, ready to use and available in three distinct levels. Each level can be ordered separately. Part Number Description Kit Size Par TDM Level 1 6 x 5 ml Par TDM Level 2 6 x 5 ml Par TDM Level 3 6 x 5 ml Analytes Acetaminophen Amikacin Caffeine Carbamazepine Digoxin Disopyramide Estriol Ethanol Ethosuximide Gentamicin Lidocaine Lithium Methotrexate N-acetylprocainamide (NAPA) Phenobarbital Phenytoin Primidone Procainamide Quinidine Salicylate Theophylline Thyroid Stimulating Hormone (TSH) Thyroxine, Total (TT4) Tobramycin Tricyclic Antidepressants Triiodthyronine, Total (TT3) Valproic Acid Vancomycin TDM Specialty Controls These specialty controls are liquid, ready-to-use, human serum controls with low, medium and high ranges of the analytes. The controls come in kits containing three levels. Part Number Description Kit Size Lamotrigine Control Set 3 levels 1 x 2.5 ml each Teicoplanin Control Set* 3 levels 1 x 2.0 ml each Topiramate Control Set 3 levels 1 x 2.0 ml each Zonisamide Control Set 3 levels 1 x 2.0 ml each Refer to the catalog or webpage for our complete listing of controls. *Teicoplanin is not available for sale in the US. 6

7 INDIKO / INDIKO PLUS Consolidate all of your drug testing (TDM, as well as ISD and DAT, using MAS controls) on a single, compact, low volume platform. Indiko s continually growing menu allows labs to perform on-demand specialty testing eliminating the need to send out samples or consume open channels on high throughput analyzers. The instruments have very low sample volume requirements (~12µL for most TDMs) resulting in more tests per kit. Additionally, it can use sample cups for low volume pediatric samples to full test tubes without designated racks. Vials can also be bar-coded for automatic patient result tracking. Indiko System Reagents provide the same accuracy, precision and sensitivity you can expect from all Thermo Scientific test kits. Indiko applications are also available for Gabapentin, Levetiracetam and Methotrexate from ARK Diagnostics, Inc. Contact us for more information. 7

8 Thermo Scientific Complete Solutions for Therapeutic Drug Monitoring Assay Type Assay Name Technology Antibiotic Antibiotic Antibiotic Amikacin Gentamicin Teicoplanin* Indiko CEDIA Indiko Indiko Reagent Part Number Calibrator Part Number Antibiotic Tobramycin Indiko Antibiotic Vancomycin Indiko Control Part Number Antiepileptic Carbamazepine CEDIA Antiepileptic Lamotrigine Indiko Antiepileptic Phenobarbital CEDIA Antiepileptic Phenytoin CEDIA Antiepileptic Topiramate Indiko Antiepileptic Valproic Acid CEDIA Antiepileptic Zonisamide Indiko Antiarrhythmics Digoxin DRI 1669 included in kit Antiarrhythmics Digitoxin CEDIA included in kit CAI-XL4 Antiarrhythmics Lidocaine Antiarrhythmics N-Acetylprocainamide (NAPA) CEDIA Antiarrhythmics Procainamide CEDIA Antiarrhythmics Quinidine Bronchodilator Theophylline CEDIA *Teicoplanin is not available for sale in the US. 8

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